The HDR Vision is intended to be used as a miversal diagnostic imaging system for radiographic and finoroscopic studies. Using a digital flat detector, it can perform a range of applications including general RIF, angiography and pediativ examinations. The HDR Vision is a device intended to visualize anatomical structures by converting a pattern of X-ray into a visible image. The system has medical applications ranging from but not limited to gastroninal examinations, cramil, skeletal, procecc and hing exposures as well as examination of the units may also be used in lymphography, endocony, myelography, venggraphy, pediatrics, arthrography, interventional radiology, digital angiocraphy and digital subtaction angiography (DSA). HDR Vision may be used for outpatient and emergency treatment, as well as for mobile transport (wheelchair and bed) examinations.
Device Story
HDR Vision is a universal diagnostic X-ray system for radiographic and fluoroscopic imaging. Input: X-ray patterns converted to visible images via digital flat panel detector (Trixell Pixium RF 4343). Operation: System integrates X-ray tube, generator, collimator, and detector; configurable as single-tube or with overhead tube crane and bucky wall stand. Used in clinical settings (outpatient, emergency, mobile transport) by healthcare professionals. Output: Digital images displayed and transmitted to external devices. Clinical utility: Visualization of anatomical structures for diagnostic procedures (e.g., GI, skeletal, angiography). Benefits: Enables broad range of diagnostic exams including pediatric and interventional radiology. Safety: System includes visual/audible warnings and automated error monitoring/blocking.
Clinical Evidence
Bench testing only. No clinical data provided. The device relies on substantial equivalence to the predicate system and adherence to established performance standards for diagnostic X-ray equipment.
Technological Characteristics
Universal R/F system; utilizes ionizing radiation. Components: X-ray tube/housing, generator, collimator, Bucky wall stand, and Trixell Pixium RF 4343 digital flat panel detector. Configurable as single-tube or with 3D overhead tube crane. Connectivity: Image transmission to external devices. Safety: Visual/audible warnings, automated error monitoring/system blocking. Complies with 21 CFR Subchapter J (Federal Diagnostic X-ray Equipment Standard).
Indications for Use
Indicated for radiographic and fluoroscopic diagnostic imaging of head, chest, abdomen, spine, neck, and limbs. Applicable for gastrointestinal, skeletal, thoracic, lung, urogenital, lymphography, endoscopy, myelography, venography, arthrography, interventional radiology, and digital angiography/DSA. Suitable for pediatric, outpatient, emergency, and mobile transport patients. Excludes mammography and computed tomography.
Regulatory Classification
Identification
An image-intensified fluoroscopic x-ray system is a device intended to visualize anatomical structures by converting a pattern of x-radiation into a visible image through electronic amplification. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.
Special Controls
*Classification.* Class II (special controls). An anthrogram tray or radiology dental tray intended for use with an image-intensified fluoroscopic x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9. In addition, when intended as an accessory to the device described in paragraph (a) of this section, the fluoroscopic compression device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
Predicate Devices
Siemens Medical Systems AXIOM Luminos dRF (K062623)
Submission Summary (Full Text)
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K081073
## DEC 0 5 2008
# Pausch. LLC 510(k) Pre-market Notification; HDR Vision
Date: Submitter's Name: Submitter's Address:
Submitter's Contact: Submitter's Telephone Number: Submitter's Fax Number:
510(k) Summary
March 28th, 2008 Pausch, LLC 808 Shrewsbury Avenue Tinton Falls, NJ 07724-3002 Justin Tice. President (732) 747-6110 (732) 747-6882
Establishment Registration Number:
2243057
#### · Device Name and Classification
| Trade Name: | HDR Vision | CFR Section: | 21 CFR § 892.1650 |
|-----------------------|-------------------------------------------------|---------------|-------------------|
| Classification Panel: | Radiology | Device Class: | Class II |
| Classification Name: | Image intensified fluoroscopic X-ray System | Device Code: | MQB, OWB, JAA |
| Common Name: | Fluoroscopic digital flat panel detector system | | |
| Performance Standard: | 21 CFR Subchapter J,<br>Federal Diagnostic X-ray Equipment Standard |
|----------------------------------------------------------|-----------------------------------------------------------------------------|
| Predicate Device Claiming<br>Substantial Equivalence to: | Siemens Medical Systems AXIOM Luminos dRF<br>510(k) Control Number: K062623 |
Reason For Submission
New device
#### Description of this Device:
The HDR Vision is intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic studies.
The HDR Vision is a device intended to visualize anatomical structures by converting a pattern of X-ray into a visible image. The system has medical applications ranging from but not limited to gastrointestinal examinations, cranial, skeletal, thoracic and lung exposures as well as examination of the urogenital tract. The units may also be used in lymphography, endoscopy, myelography, venography, pediatrics, arthrography, interventional radiology, digital angiography and digital subtraction angiography (DSA).
## Summary of Intended Uses:
This system is intended for use as a general radiography device for the head, chest, abdomen, spine, neck and limbs. This system is used for image acquisition, image display, and the transmission/output of images to external devices. Excluded indications include mammography, computed tomography. HDR Vision is a universal fluoroscopic x-ray diagnostic system (RIF system), with an overtable X-ray
510k Summarv
Section H Page 1 of 2
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tube assembly. Using a digital flat detector, it can perform a range of applications including general R/F, angiography and pediatric examinations.
The HDR Vision with Flat Detector is substantially equivalent to the commercially available AXIOM Luminos dRF with Flat Detector Siemens system.
The AXIOM Luminos dRF with Flat Detector, and generally marketed as the AXIOM Luminos dRF, was described in premarket notification K062623 which received FDA Clearance on August 22, 2007.
The Flat Panel Detector Pixium RF 4343 manufactured by Trixell and equipped with the HDR Vision is substantially equivalent to the Pixium 5100 manufactured by Trixell and equipped with the AXIOM Luminos dRF that was described in premarket notification K062623 which received FDA Clearance on August 22, 2007.
HDR Vision can be configured as a single tube system, with only an overtable tube or it can be combined with an additional 3D overhead tube crane, that can be moved longitudinally and laterally as well as vertically and a bucky wall stand.
## Technological Characteristics:
This device employs similar materials and processes as found in the predicate device. The device produces ionizing radiation that is employed to generate radiographic and fluoroscopic images of the anatomy. HDR Vision is not a stand-alone device, but functions as the platform for specific X-ray components, X-ray tube and housing, flat detector, digital imaging system, Bucky wall stand, collimator, generator etc. Many of the components used in HDR Vision are either commercially available with current Pausch systems or include minor modifications to existing components.
### Safety and Effectiveness Concerns:
Instructions for use are included within the device labeling, and the information provided will emable the user to operate the device in a safe and effective manner. Several safety features including visual and audible warnings are incorporated into the system design. In addition the HDR Vision is continually monitored, and if an error occurs, the system functions will be blocked and an error message will be displayed.
Furthermore the operators are health care professionals familiar with, and responsible for, the X-ray examinations to be performed. To minimize electrical, mechanical and radiation hazards, Pausch adheres to recognized and established industry practice, and all equipment is subject to final performance testing.
#### Conclusion:
The HDR Vision complies with the same or equivalent standards and has the same intended use as the predicate device and does not raise new questions of safety or effectiveness and is substantially equivalent to the Siemens AXIOM Luminos dRF; K062623 (August 22, 2007).
Bnd of 510(k) Summary.
510k Summary
Section H Page 2 of 2
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Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services. The logo consists of a symbol on the left and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" on the right. The symbol features a stylized human figure with outstretched arms, and the text is in a clear, sans-serif font.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
Mr. Justin Tice President PAUSCH LLC 808 Shrewsbury Avenue TINTON FALLS NJ 07724
JUL 30 2012
Re: K081073 Trade/Device Name: HDR Vision Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Code: OWB. JAA. and MOB Dated: October 16, 2008 Received: October 17, 2008
Dear Mr. Tice:
This letter corrects our substantially equivalent letter of December 5, 2008.
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of
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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in vour Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely Yours,
Janine M. Morris
Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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# Indications for Use
5.10(k) Number (if known):
Device Name: HDR Vision
Indications For Use:
The HDR Vision is intended to be used as a miversal diagnostic imaging system for radiographic and finoroscopic studies. Using a digital flat detector, it can perform a range of applications including general RIF, angiography and pediativ examinations.
The HDR Vision is a device intended to visualize anatomical structures by converting a pattern of X-ray into a visible image. The system has medical applications ranging from but not limited to gastroninal examinations, cramil, skeletal, procecc and hing exposures as well as examination of the units may also be used in lymphography, endocony, myelography, venggraphy, pediatrics, arthrography, interventional radiology, digital angiocraphy and digital subtaction angiography (DSA).
HDR Vision may be used for outpatient and emergency treatment, as well as for mobile transport (wheelchair and bed) examinations.
(Please do not write below this line - continue on another page if needed) Concurrence of the CDRH, Office of Device Evaluation (ODE)
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Division of Reproductive, Abdomin
f Reproductive, Abdominal,
and Radiological Devices
510(k) Number K081073
Page 1 of 1
Indications for use without Letterhead
Section G Page 1 of 1
Two short videos show you everything — or skip straight to the written tutorial if you'd rather read. You can reopen this any time from the Tutorial button in the top bar.
Part 1 — Search, results, and everyday workflows 16 min
Part 2 — Embeddings: the galaxy map 3 min
1. Search: exact and fuzzy
Type a phrase like "coronary artery calcification" into the search box. You get two kinds of results. Exact results match the literal phrase — prefix searches work ("coronary artery calcificati") but suffix searches do not. Fuzzy results match on the meaning and intent of your phrase rather than the exact words, and are sorted by relevance score. Hover over the Exact or Fuzzy badge on any row to see exactly why it matched.
Use the checkboxes above the results to narrow: SaMD keeps only software-only devices, AI / ML keeps only devices with AI.
Exact vs. fuzzy search: what's the difference?
Exact matches on the literal phrase (prefix search works, suffix does not). Fuzzy matches on the meaning and intent of the phrase rather than the exact words. Hover over the badge on any row to see why it matched.
You search "coronary artery calcification" and want only software devices with AI. What two filters do you apply?
Narrow by SaMD (software-only devices), then narrow by AI/ML (devices with AI).
2. The results table
Scroll right in the results table. The intended use is extracted for you — no need to open the PDF. The device story gives a high-level snapshot of what the device does and how it's used. The AI Performance sub-table shows each output name, acceptance criteria, observed values, and development/test dataset descriptions — the same format Innolitics uses for regulatory strategy outputs, and the fastest high-level fingerprint of an AI device. It is AI-generated but has been very reliable in practice.
Where do you find a device's intended use without opening the PDF?
Scroll right in the search results table. The intended use column is extracted for you; no need to dig into the 510(k) summary PDF.
What does the AI Performance sub-table show, and why is it useful?
Output name, acceptance criteria, observed values, development dataset description, and test dataset description. It's the same format we use for regulatory strategy output and Fast 510(k) input, and the fastest high-level fingerprint of an AI device. AI-generated but reliable in practice.
3. Judging fuzzy relevance
Fuzzy results trail off in relevance as you scroll. Use three signals to decide how far down to go: the fuzzy badge explanations, the intended use column, and whether your target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, you're past the relevant zone. A top hit with a low score (~0.4) and a stretched explanation is a hint the closest predicates are far away — the project may be headed for De Novo. Note the fuzzy search is a pattern match: it doesn't handle negation ("not") well, and hardware devices can appear — filter by SaMD/AI ML to cut them.
How do you judge how far down fuzzy search results to go?
Use the relevancy signals: the fuzzy badge explanations, the intended use column, and whether the target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, results are trailing off in relevancy.
4. Device detail page: chat and citations
Click a device name to open its detail page: device facts on the left, a chat window on the right. Ask something like "Describe the training data". The answer carries little citation bubbles — click one to jump to the highlighted passage in the source PDF, so you can verify every AI answer against the document. There's also a Download PDF button for sharing.
How do you verify an AI chat answer on the device detail page?
Click the citation bubbles to jump to the relevant highlight in the source document.
Reading rule for every project: how many summaries do you read in full?
At least the three most relevant 510(k) or De Novo summaries, in full. After that, use targeted chat questions to confirm your memory quickly. The tool supports this professional habit — it doesn't replace it.
5. Side-by-side comparison
Select multiple rows in the results table (aim for under ~10), then open the PDF Viewer tab. Ask one question — it goes to all selected devices in parallel, each with citations. This is the fastest way to compare and contrast devices: training data, PCCP scope, how they handled adding new scanners, and so on.
What does the side-by-side PDF viewer mode do?
Select multiple devices, open the PDF viewer tab, and ask one question (e.g., "Describe the training data"). It queries all selected devices simultaneously with citations, so you can compare and contrast quickly.
6. Collections
With rows selected, go to the Collections tab and create a labeled collection (e.g., "Cobb Angle Project"). Reload that selection any time — before a client call, pull up the collection and ask questions across all of its devices at once.
How do you save a set of selected devices for later use?
Select the rows, go to the Collections tab, and create a labeled collection (e.g., "Cobb Angle Project"). You can reload the selection anytime and carry it into the PDF viewer and other tabs that support selections.
7. Product codes and the regulations tree
Click a product code in the results to jump to it in the regulations tree — identification text, sibling product codes, and devices you can open in a PDF viewer on the right. Click a regulation number to see its identification, special controls, and related product codes. You can also search by product code or regulation number at the top of the tree. Always read the special controls if any exist for your device — it broadens your search and sharpens pre-kickoff research.
What can you do from the regulations tree view?
Browse product codes and regulation numbers, read the identification text and special controls, browse sibling product codes, open device PDFs on the right, and search by product code or regulation number at the top of the tree.
8. Chart view
Click Show Chart and segment by regulation number (or product code) to see which regulations dominate your result set. Clicking a regulation takes you into the regulations tree. Great for spotting that most matches are, say, hardware laparoscopic devices — a cue to go back and filter.
How do you see which regulations dominate a search result set?
Click "Show Chart" and segment by Regulation Number. Clicking a regulation takes you to the regulations tree.
9. The predicate graph
Open the Predicates tab for a family-tree view of predicate relationships. Click a node to trace its parents and children; selections from search carry over pre-selected. Commonly predicated devices are worth reading — a lot of people predicated them for a reason. The visual lineage is also handy on client calls, e.g. to show how a predicate family evolved and justify why your predicate still holds.
In the predicate graph, why are commonly predicated devices worth reading?
A lot of people predicated them for a reason. Clicking a node traces parents and children, and selections from search carry over pre-selected.
10. Embeddings: the galaxy map
The Embeddings tab plots every matching document in a 2-D "galaxy map" where semantically similar devices cluster together. Hover or click clusters to explore, and let AI label the clusters for you. Embeddings beat product codes for grouping: two devices can carry different product codes (LLZ vs. QIH) yet do the same thing — the embedding captures the meaning of the intended use and device story. This is also exactly how retrieval-augmented generation (RAG) works under the hood, and it makes a great visual on client calls.
Try it yourself
Head to the search page and work through a few of these AI/ML fuzzy searches to build intuition: perivascular fat on CT · aortic valve calcification opportunistic screening on noncontrast CT · breast cancer prediction on digital pathology slides · autism detection · gestational age prediction · a hearing aid that can also detect a pulse · foundation model based analysis of ECG · large language models · penetration test. Watch how the relevance scores, intended use, and AI Performance tables tell you when results stop being meaningful.
